As Abiraterone and Enzalutamide Gain Traction in the Market, What Key Attributes Do Oncologists and Payers Say Will Differentiate Emerging Therapies?

The first-line (chemotherapy-naive) metastatic castrate-resistant prostate cancer (mCRPC) market is becoming increasingly crowded. In recent years, several new, high-priced therapies have been approved for use in this patient population, making this lucrative market more dynamic and competitive. The launch of these agents has significantly altered the treatment algorithm and improved the outlook for patients; nevertheless, our research indicates that significant clinical and commercial opportunity remains for therapies that can further extend overall survival. Several therapies are in late-stage development for first-line (chemotherapy-naive) mCRPC, though we do not we anticipate that all of these agents will be approved for this indication.

Questions Answered in This Report:

  • A drug’s performance on at least seven efficacy end points, including median overall survival, is important for drug approval and physician use. What are the key primary and secondary clinical trial end points with which new therapies are evaluated? How do U.S. and European oncologists weight efficacy measures and other drug attributes in their prescribing decisions for first-line (chemotherapy-naive) metastatic castrate-resistant prostate cancer (mCRPC)?

  • Increased overall survival, delayed disease progression, and improved symptom control and quality of life are key areas of unmet need for first-line (chemotherapy-naive) mCRPC according to the insights of surveyed U.S. and European oncologists.  Which therapies in development for first-line (chemotherapy-naive) mCRPC are poised to fulfill these needs? What clinical and/or regulatory challenges must drug developers overcome in order to capitalize on these areas of unmet need? What degree of improvement over currently available therapies do surveyed U.S. MCO PDs seek from new therapies on key clinical attributes for which surveyed physicians indicate there is high unmet need?

  • Median overall survival and radiographic progression-free survival are key drivers of physicians’ prescribing decisions and/or are the focus of drug development for new first-line (chemotherapy-naive) mCRPC therapies. What trade-offs across these and other clinical attributes are U.S. oncologists willing to make when considering the use of emerging therapies for the treatment of first-line (chemotherapy-naive) mCRPC? Based on the trade-offs in price and performance across key drug attributes that U.S. oncologists are willing to make, how do physician preference and prescribing likelihood vary across different target product profiles for first-line (chemotherapy-naive) mCRPC?

  • Based on its clinical profile, enzalutamide (Medivation/Astellas Pharma’s Xtandi) is the current clinical gold standard in our Drug Comparator Model. What attributes do thought leaders believe differentiate this therapy from competing current therapies and emerging therapies? Will any therapies in development challenge enzalutamide as the gold standard for 2017 or 2022?

Scope:

Attributes included in conjoint analysis-based assessment of target product profiles for first-line (chemotherapy-naive) mCRPC:

- Median overall survival (months).

- Median radiographic progression-free survival (months).

- Median time to increase in pain (months).

- PSA response rate (% of patients), defined as a ≥ 50 % decline in serum PSA.

- Incidence of diarrhea (all grades) (% of patients).

- Incidence of fatigue (all grades) (% patients).

- Price per course of treatment.

Attributes included in assessment of U.S. payers’ receptivity to new therapies for first-line (chemotherapy-naive) mCRPC:

- Effect on median overall survival.

- Effect on radiographic progression-free survival.

- Effect on PSA response.

- Effect on incidence of fatigue (all grades).

Physicians surveyed: 61 U.S. and 30 European oncologists.

Payers surveyed: 20 U.S. MCO PDs.

Comprehensive List of Therapies Included in Our Research and Modeling:

Current Therapies

- Sipuleucel-T (Dendreon’s Provenge)

- Docetaxel (Sanofi’s Taxotere, generics)

- Abiraterone (Johnson & Johnson/Janssen Biotech/Janssen-Cilag’s Zytiga)

- Enzalutamide (Medivation/Astellas Pharma’s Xtandi)

- Radium-223 (Algeta/Bayer HealthCare’s Xofigo)

Emerging Therapies

- Rilimogene galvacirepvec (prostvac-VF-TRICOM) (Bavarian Nordic)

- Orteronel (Millennium/Takeda)

- Ipilimumab (Bristol-Myers Squibb’s Yervoy)

- Tasquinimod (Active Biotech/Ipsen)

- Custirsen (OncoGenex/Teva) + docetaxel (Sanofi’s Taxotere, generics)


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